30 January 2018 EMA/CVMP/PhVWP/384293/2017 Committee for Medicinal Products for Veterinary Use (CVMP)

Work plan for the CVMP Pharmacovigilance Working Party (PhVWP-V) 2018

Chairpersons

Status

Chair: E. Dewaele

Adopted by CVMP in December 2017

Vice-chair: E. Bégon The activities outlined in the work plan for 2018 have been agreed considering the respective business priorities, as well as the Agency’s relocation as a result of the UK’s exit from the EU and its impact on the Agency’s business continuity, and may be subject to further review and reprioritisation in accordance with the business continuity plan of the Agency.

1. Meetings scheduled for 2018 Plenary meetings:

5 (per meeting: 28 members, 1 day) 23-24 January 2018 20-21 March 2018 29-30 May 2018 25-26 September 2018 20-21 November 2018

Other meetings: Topic virtual meetings

Pharmacovigilance surveillance meeting July 2018

Drafting / Expert groups

5 physical meetings in the margins of plenary meetings as needed (4-5 participants)

Workshop / Focus group

1 focus group with specialised veterinarians/healthcare professionals for poultry on promotion of pharmacovigilance to improve reporting and provision of feedback

30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

An agency of the European Union

© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Training

1 for assessors (advanced EudraVigilance Veterinary (EVVet), data warehouse (DWH)/signal detection) Bi-monthly virtual training meetings to support assessors on the use of DWH and the signal detection queries.

Virtual meetings are mainly regarded as complementary to plenary meetings. However, if feasible and depending on the workload, one of the plenary meetings could be replaced by a virtual meeting.

2. Product related issues Undertakings on behalf of or upon request from CVMP On behalf of the Committee for Medicinal Products for Veterinary Use (CVMP), the Pharmacovigilance Working Party (PhVWP-V) systematically and continuously reviews pharmacovigilance data for centrally authorised veterinary medicinal products to identify potential problems and/or the need for further investigations and recommendations for regulatory action. Upon request, the PhVWP-V will review and advise on periodic safety update reports (PSURs), referral procedures and other specific scientific requests related to pharmacovigilance of products, including recommendations for regulatory measures in relation to risk management. Furthermore the PhVWP-V will address any specific scientific requests relating to veterinary pharmacovigilance in general. The PhVWP-V is also expected to have a role in the supervision and pre-evaluation of the data to be released to healthcare professionals and the general public. The following table provides the expected number of contributions (number of involvements) per year for product assessment, including pre- and post-authorisation issues, in addition to the ongoing surveillance of centrally authorised products. Expected contribution in scientific advice

Expected contribution in product assessment

0

0-1

Undertakings on behalf of or upon request from Member States On behalf of the Member States, the PhVWP-V also reviews pharmacovigilance data for nationally authorised veterinary medicinal products, including products authorised via the mutual recognition or the decentralised procedure. Upon request, the PhVWP-V will review and advise on PSURs, CMD(v) referral procedures and other specific scientific requests related to pharmacovigilance of products, including recommendations for regulatory measures in relation to risk management. Furthermore the PhVWP-V will address any specific scientific requests relating to veterinary pharmacovigilance in general. The PhVWP-V is also expected to have a role in the supervision and pre-evaluation of the data to be released to healthcare professionals and the general public. The following table provides the expected number of contributions (number of involvements) per year for product assessment, including pre- and post-authorisation issues. Expected contribution in scientific advice

Expected contribution in product assessment

N/a

3-4

Work plan for the CVMP Pharmacovigilance Working Party (PhVWP-V) 2018 EMA/CVMP/PhVWP/384293/2017

Page 2/6

EVVet and the EVVet DWH will be used for the systematic surveillance of adverse events across the European Union. The increased availability of product data in a central database (EU veterinary medicinal product database 1 (EU VMPD)) will facilitate and enhance surveillance on an EU-scale which, in particular, will be of benefit to smaller Member States with limited resources.

3. CVMP guidance documents 3.1. Guidance documents to be finalised after the consultation period 3.1.1. Combined Veterinary Dictionary for Drug Related Affairs (VeDDRA) list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (EMA/CVMP/10418/2009) Action:

Annual review of the standard lists used for reporting adverse events by the VeDDRA sub-group with industry participation and involving VICH partners (Q3 2018). Additionally, input will be given into Controlled Term Lists for the European Union Telematics Controlled Terms (EUTCT) project (as contained within the EU Telematics Master Plan endorsed by the European Medicines Agency Management Board and Heads of Medicines Agency (HMA)) as necessary.

Comments:

Revision of existing guidance. Deadline for comments: 1 March every year. Annual VeDDRA review scheduled for April 2018. Implementation in EVVet: 1 October every year. N.B. The update of VeDDRA will be suspended for 2019, due to reduction of Agency activities as part of the Brexit Business Continuity Plan.

3.1.2. Revised recommendation for the basic surveillance of EudraVigilance Veterinary (EVVet) data for centrally authorised products (CAPs) (EMA/CVMP/PhVWP/471721/2006-Rev.1) Action:

Finalise revised recommendation (Q2 2018).

Comments:

Following public consultation (Q2 2017) and taking into account experience gained during pilot to implement the revised recommendation (pilot: Q3 2017 – Q1 2018).

3.2. Guidance documents to be released for consultation None.

3.3. New topics/concept papers to be prepared 3.3.1. Promotion of pharmacovigilance reporting Action:

Develop concept for strategy for handling promotion of pharmacovigilance reporting and providing feedback to reporters on food producing animals (Q2 2018).

Comments:

Pending further input from HMA-V ESS and stakeholders i.e. veterinarians/healthcare professionals, in particular specialised in food-producing species, via a series of focus

1

http://vet.eudrapharm.eu

Work plan for the CVMP Pharmacovigilance Working Party (PhVWP-V) 2018 EMA/CVMP/PhVWP/384293/2017

Page 3/6

groups to establish potential collaborative network and continue dialogue with specialist stakeholders to identify gaps and potential opportunities, including practical measures for improving pharmacovigilance reporting and providing feedback to reporters. The first focus group will consider poultry (Q3 2018) and future focus groups will address other food-producing species groups.

3.3.2. Pharmacovigilance communication Action:

Reflect on how to improve communication on Pharmacovigilance issues (Q3-Q4 2018).

Comments:

None.

4. VICH guidelines and international standards activities 4.1. Review of VICH pharmacovigilance guidelines: GL30: controlled list of terms; GL35: electronic standards for transfer of data and GL42: data elements for submission of adverse event reports Action:

Annual review of controlled list of terms and to review the proposed ‘Acknowledgment message’ standard.

Comments:

None.

4.2. Support the work of the electronic standards implementation expert working group (ESI-EWG) on proposed solutions to specific elements of regional disharmonisation hereby identifying specific parts of the VICH pharmacovigilance guidelines that would require updating Action:

Provide input to the ESI-EWG to investigate and propose specific solutions and necessary updates to the current VICH pharmacovigilance guidelines taking into account elements of regional disharmonisation as identified by industry.

Comments:

The discussions will be framed by both the current implemented United States (US) legislative requirements as well as the draft proposals foreseen as part of the upcoming revision of the EU legislative framework.

5. EU regulatory activities 5.1. For CVMP 5.1.1. Veterinary pharmacovigilance public bulletin Action:

Publish the veterinary pharmacovigilance annual bulletin, which summarises data collected in 2017 and pharmacovigilance activities from that year (Q1 2018).

Comments:

The annual summary has a specific focus on CAPs.

Work plan for the CVMP Pharmacovigilance Working Party (PhVWP-V) 2018 EMA/CVMP/PhVWP/384293/2017

Page 4/6

5.1.2. Targeted analysis of anti-parasitic adverse event data Action:

Conduct an active substance class-based analysis of anti-parasitic CAPs including developing methodology and undertaking a critical evaluation of the analytical tools for best use of the data available in EVVet (Q4 2018).

Comments:

Pending endorsement of mandate by CVMP.

5.1.3. CVMP pharmacovigilance issues Action:

At the request of CVMP, provision of advice on individual pharmacovigilance issues concerning CAPs for identification and evaluation of potential safety concerns and risk management relating to these.

Comments:

Advice will be provided as necessary.

5.2. For Member States 5.2.1. Member States’ pharmacovigilance issues Action:

At the request of Member States (including CMDv), provision of advice on individual pharmacovigilance issues on the basis of information provided concerning NAPs for identification and evaluation of potential safety concerns and risk management relating to these. In addition, advice may also be requested regarding the new EU legislative proposals, when available.

Comments:

Advice will be provided as necessary.

5.3. Assessor training 5.3.1. Veterinary training curriculum Actions:

Provide veterinary training in line with the Pharmacovigilance curriculum (EVVet Data Warehouse) Provide advice/active participation for other training sessions for assessors, as required.

Comments:

None.

5.3.2. EVVet Data Warehouse and signal detection Action:

Bi-monthly virtual training meetings to support assessors on the use of DWH and the signal detection queries. Provide advice/active participation for other training sessions for assessors, as required.

Comments:

This ongoing activity is distinct from the advanced EVVet training course (see section 1 Other meetings (training)).

Work plan for the CVMP Pharmacovigilance Working Party (PhVWP-V) 2018 EMA/CVMP/PhVWP/384293/2017

Page 5/6

6. Activities with external parties 6.1. Meetings with interested parties One with pharmaceutical industry, public health stakeholders, learned societies.

6.2. Regulatory authorities outside the EU None foreseen.

7. Organisational matters 7.1. List of adopted organisational documents Mandate, objectives and rules of procedure for the CVMP Pharmacovigilance Working Party (EMA/CVMP/PhVWP/133883/2004-Rev.3).

7.2. List of organisational documents to be developed/revised in the forthcoming 2 years Mandate, objectives and rules of procedure for the CVMP Pharmacovigilance Working Party (EMA/CVMP/PhVWP/133883/2004-Rev.3).

7.3. List of proposed scientific guidance documents for the next work plan Development of concept paper outlining principles and tools for surveillance of NAPs in line with the methodology outlined in revised recommendation for the basic surveillance of EVVet data for centrally authorised products (CAPs).

Work plan for the CVMP Pharmacovigilance Working Party (PhVWP-V) 2018 EMA/CVMP/PhVWP/384293/2017

Page 6/6

Work plan for the CVMP Pharmacovigilance Working Party - European ...

recommendations for regulatory measures in relation to risk management. ... and humans to veterinary medicinal products (EMA/CVMP/10418/2009). Action:.

105KB Sizes 0 Downloads 276 Views

Recommend Documents

Work Plan for the CVMP Pharmacovigilance Working Party - European ...
Dec 8, 2016 - regulatory measures in relation to risk management. ... Master Plan endorsed by the European Medicines Agency Management Board and ...

Work plan for the CVMP Safety Working Party - European Medicines ...
EMA/CVMP/SWP/278493/2017. Committee for Medicinal Products for Veterinary Use (CVMP). Work plan for the CVMP Safety Working Party (SWP-V). 2018. Chairpersons. Status. Chair: E. Lander Persson. Vice-chair: S. Scheid. Adopted by CVMP in December 2017.

Work plan for the CVMP Scientific Advice Working Party - European ...
European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 7 December 2017. EMA/CVMP/SAWP/574285/2017. Committee for Medicinal Products for Veterinary Use (CVMP). Work plan for the CVMP Scientific Advice Working

Work plan for the CVMP Immunologicals Working Party - European ...
European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 7 December 2017. EMA/CVMP/IWP/347865/2017. Committee for Medicinal Products for Veterinary Use (CVMP). Work plan for the CVMP Immunologicals Working Part

Work plan for the Blood Product Working Party (BPWP) - European ...
Jul 20, 2017 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom .... Support to and cooperation with EU institutions and Network.

Work plan for the Pharmacokinetics Working Party (PKWP) - European ...
14 Dec 2017 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union. Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website www.ema.europa.eu/contact. © Europ

Work plan for the Pharmacogenomics Working Party - European ...
Dec 15, 2016 - Concept paper on the Co-development of biomarker-based ... Contribution to the development of the revised guideline with regards to.

Work plan for the Cardiovascular Working Party (CVSWP) - European ...
Dec 14, 2017 - An agency of the European Union. Telephone +44 ... ad-hoc to respond to time-sensitive requests on products and to progress guidelines, as required. Page 2. Work plan for the Cardiovascular Working Party (CVSWP) for 2018. EMA/CHMP/3655

Work plan for the joint CHMP / CVMP Quality Working Party 2016
Jan 24, 2017 - ... quality requirements of medicinal products containing a device component for delivery or .... Training for the network and knowledge building.

4029 WIN - Organisation of CVMP Working Party meetings - European ...
WPs/For secretariats). Send an email to the members of the relevant WP (cc the WP inbox, if ... following link: https://access.ema.europa.eu/sslvpn. You will find ...

4029 WIN - Organisation of CVMP Working Party meetings - European ...
(laptop/desktop) on the MMD login page. Please remember to use the Table of Content document .... Page 9/14. Annex I. Lists of permanent agenda points. AWP.

Work plan for the Central Nervous System Working Party 2017
Dec 15, 2016 - Guideline on the clinical development of medicinal products for the ... The guideline was developed in collaboration with BSWP, PDCO and ...

Work plan for the Rheumatology Immunology Working Party (RIWP ...
14 Dec 2017 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the European Union. Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555. Send a question via our website www.ema.europa.eu/contact. © Europ

Work plan for the Biosimilar Medicinal Products Working Party 2016
Dec 15, 2016 - Contribution to tailored scientific advice procedure including an in-depth review of quality, analytical and functional data for biosimilar medicinal ...

Work plan for the Vaccines Working Party (VWP) for 2017 - European ...
Dec 15, 2016 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. An agency of the ... Send a question via our website www.ema.europa.eu/contact ... Training for the network and knowledge building ... vaccines to discuss how b

Work plan for the Biologics Working Party (BWP) for 2017 - European ...
Dec 15, 2016 - Development of a draft points to consider document is to be initiated in Q2 2017 ... Joint CVMP/CHMP ad hoc expert group on application of the 3Rs .... products under accelerated access schemes (Adaptive pathways and ...

Work plan for the Working Party on European Union Monographs and ...
Send a question via our website www.ema.europa.eu/contact. © European .... Develop HMPC guidelines and guidance documents. Upon request from the ...

Public CVMP work plan - 2017 - European Medicines Agency
Dec 8, 2016 - Application of the 3Rs in Regulatory Testing of Medicinal Products (3R's) .................. 9 ... intended to stimulate development of new veterinary medicines for minor species and/or for rare diseases in .... throughout their lifecyc

Work plan for the joint CVMP/CHMP working group on the application ...
Committee for Medicinal Products for Human Use (CHMP). Committee for Medicinal Products for Veterinary Use (CVMP). Work plan for the joint CVMP/CHMP working group on the application of the 3Rs (replacement, reduction and refinement) in regulatory tes

Work Plan 2017 GCP Inspectors Working Group - European ...
Jan 12, 2017 - to develop new, and revise existing document such as EMA GCP inspection ... trends to be followed in the period 2017-2018; ... in MS, in third countries and inspections conducted in the framework of an application for a.

Standard operating procedure for European Pharmacovigilance ...
2012 and after. 7. Definitions. EPITT: European Pharmacovigilance Issues Tracking Tool is a web- based system that tracks and monitors the safety of medicinal.

Work plan for the Organisational Matters Drafting Group - European ...
Send a question via our website www.ema.europa.eu/contact. © European ... clarify criteria on need, trigger, timelines and scope of revisions and develop a.

Work plan for the European Medicines Agency Human Scientific ...
Jan 25, 2017 - Also in June 2016, EMA's multiannual work programme to 2020 was published, .... of the workshops organised in 2016 on social media, mHealth/apps (IMI- ... Follow the outcome of the social media workshop held in 2016, ...

Work plan for the European Medicines Agency Human Scientific ...
Jan 25, 2017 - In June 2016 the PCWP started its new mandate for the period .... Follow the outcome of the workshops organised in 2016 on social media, mHealth/apps (IMI- ... Follow the outcome of the social media workshop held in 2016, ...